Lidocaine hydrochloride injection and preparation method thereof

Abstract

The invention provides lidocaine hydrochloride injection. Each 1000ml of the lidocaine hydrochloride injection is prepared from the following components by weight: 20g of lidocaine hydrochloride (the theoretical weight, and the quantity of lidocaine hydrochloride needs to be determined according to the content as well as the water drying and the purifying condition), and 4.4-5.3 g of sodium chloride. According to the improved lidocaine hydrochloride injection and the preparation method of the lidocaine hydrochloride injection, the prescription composition is simple, and a few kinds of auxiliary materials is adopted, thus the clinical risks caused by lack of iso-osmia of a product are eradicated, and the various index including the pH of the product and related substances are stable and controllable, and meet the requirements in the exposure draft of the lidocaine hydrochloride injection in the China pharmacopeia 2015; the lidocaine hydrochloride injection is suitable for clinical application, and the product is safe and effective. A preparation method is simple, new cost is not increased, and the lidocaine hydrochloride injection is suitable for large-scale industrial production and has a large application value.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method of the medicine, in particular to a lidocaine hydrochloride injection and a preparation method thereof. Background technique [0002] The main component of Lidocaine Hydrochloride Injection is Lidocaine Hydrochloride, which is used in this product as a local anesthetic and an antiarrhythmic drug. It is mainly used for infiltration anesthesia, epidural anesthesia, topical anesthesia (including mucosal anesthesia during thoracoscopic examination or abdominal surgery) and nerve conduction block. This product can also be used for premature ventricular contractions and ventricular tachycardia after acute myocardial infarction, and for ventricular arrhythmias caused by digitalis poisoning, cardiac surgery and cardiac catheterization. But it is usually ineffective for supraventricular arrhythmias. [0003] The indications for lidocaine hydrochloride injection are lo...

AI Technical Summary

Problems solved by technology

However, since lidocaine hydrochloride injection is often used clinically for epidural block and caudal block, this route of administration has a high risk to the human body. If the drug solution is not isotonic, it will increase the risk of clinical medication , serious and may even lead to irreversible damage or even death of the patient

However, the current version of the Chinese Pharmacopoeia Standard for Lidocaine Hydrochloride Injection does not require the osmotic pressure of the drug, which cannot avoid the risk of the product being not isotonic

At the same time, the pH standard of lidocaine hydrochloride injection in the current version of the Chinese Pharmacopoeia is pH 3.5 to 5.5, but lower pH values ​​often cause irritation in patients taking the drug, and lidocaine hydrochloride injections at lower pH values The anesthesia effect of Caine Hydrochloride Injection is not obvious, so before clinical use, medical personnel often adjust the pH of Lidocaine Hydrochloride Injection to 5.0-7.0 (clinical studies have shown that the anesthetic effect of Lidocaine Hydrochloride Injection increases with the increase of pH). Improvement, best at pH5.0~7.0)

There are also literatures that show that when the pH is greater than 6.0, the stability of the solution is relatively poor, and particles are precipitated, so it is necessary to prepare it immediately before use. However, due to the lack of necessary detection methods and the influence of the quality of personnel, this process may greatly increase the clinical the risks of drug use

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